Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers

Inclusion Criteria

• Age 18 years or older.

• Patients with more than one eligible ulcer will have one - usually the largest or more clinically significant - selected at screening as the index ulcer.

• Participants will have the capacity to understand study procedures, and will be able to providewritten informed consent.

(for VLU only)

• Diagnosed with at least one venous leg ulcer.

• Ulcers duration for 6 weeks to 3 years at the time of screening.

• Hard-to-healed ulcers with cross-sectional area that have decreased by less than 40% during a four-week run-in period.

• Reference ulcer surface from 5 to 25 cm2.

• At the time of inclusion, the ulcer will be clinically non-infected (TILI score ≥ 5).

• Absence of significant arterial insufficiency assessed at clinical examination (intermittent claudication or resting pain, necrotic or distal wound on the foot) and systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.

(for DFU only)

• Patient with type 1 or type 2 diabetes.

• Diagnosed with at least one diabetic foot ulcer on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft.

• Ulcers duration for 4 weeks to 3 years at the time of screening.

• Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four-week run-in period.

• Reference ulcer surface from 1 to 25 cm2.

• At the inclusion, the ulcer will be clinically non-infected (according to IDSA criteria).

• HbA1C < 12% at screening.

• Absence of significant arterial insufficiency assessed by systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.

Exclusion Criteria

• Subject has a history of:

• endstage renal disease

• uncontrolled cardiac failure

• severe malnutrition

• severe liver disease

• aplastic anemia

• malignant disease (active or recent (<5 years))diabetes avec HbA1C > 12%

• rheumatoid arthritis

• sickle cell disease

• other connective tissue disorder

• irradiation to the affected extremity

• Serum creatinine concentration greater than 180 umol/L and/or receipt of renal dialysis or an estimated glomerular filtration rate (based on cystatin C or serum creatinine) of less than 20 mL/min per 1·73 m²

• Drug or alcohol abuse.

• Limited physical capacity or total immobility.

• Known pregnancy or nursing at the time of screening visit

• Subject is currently receiving (i.e within 30 days prior to inclusion) or scheduled to receive a medication or treatment that, in the opinion of the investigator, will interfere with or affect the rate of wound healing.

• Index ulcers probing to tendon, muscle, capsule and bone.

• Local or systemic signs of ongoing infection.

• Hypersensitivity to silicone or porcine gelatin.

• Previous treatment with growth factors, stem cells, or an equivalent preparation within the 8 weeks before the baseline visit.

• Involvement in another interventional clinical trial within the 4 weeks before the baseline visit.

• Known or suspected absence of capacity to understand the study procedures or provide written informed consent (decided by the investigator).

• Cross-sectional area of the index ulcer had increased by at least 20%.

(for VLU only)

• History of poor compliance with compression therapy.

• Presence of peripheral neuropathy of the lower limbs.

(for DFU only)

• History of poor compliance with offloading therapy.